Table 4.
Treatment-emergent SAEs across age groups, by preferred term (safety analysis set)
| Aged < 40 years, n (%) | Placebo (n = 597) | Erenumab 70 mg (n = 514) | Erenumab 140 mg (n = 382) | Erenumab 70 + 140 mg (n = 896) | Total (N = 1493) |
| Number of participants with at least one SAE | 7 (1.2) | 6 (1.2) | 2 (0.5) | 8 (0.9) | 15 (1.0) |
| Asthenia | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Cholelithiasis | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Hypersensitivity | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Gastroenteritis | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Labyrinthitis | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Urinary tract infection | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Gastrointestinal infection | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Parotitis | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Viral infection | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Cartilage injury | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| Flank pain | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Intervertebral disc protrusion | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Syncope | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| Migraine | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Abortion | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Ovarian cyst | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Aged 40–49 years, n (%) | Placebo (n = 421) | Erenumab 70 mg (n = 356) | Erenumab 140 mg (n = 275) | Erenumab 70 + 140 mg (n = 631) | Total (N = 1052) |
| Number of participants with at least one SAE | 8 (1.9) | 6 (1.7) | 5 (1.8) | 11 (1.7) | 19 (1.8) |
| Abdominal adhesions | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Abdominal pain | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Vomiting | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Cholelithiasis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Cholecystitis | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Cholecystitis acute | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Hypersensitivity | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Appendicitis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Clostridium difficile colitis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Kidney infection | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Pyelonephritis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Sepsis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Urinary tract infection | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Ankle fracture | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Post-traumatic neck syndrome | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Traumatic fracture | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Fall | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Costochondritis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Intervertebral disc protrusion | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Migraine | 0 | 1 (0.3) | 1 (0.4) | 2 (0.3) | 2 (0.2) |
| Abortion | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Endometriosis | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Aged 50–59 years, n (%) | Placebo (n = 262) | Erenumab 70 mg (n = 214) | Erenumab 140 mg (n = 158) | Erenumab 70 + 140 mg (n = 372) | Total (N = 634) |
| Number of participants with at least one SAE | 3 (1.1) | 4 (1.9) | 2 (1.3) | 6 (1.6) | 9 (1.4) |
| Pancreatitis | 1 (0.4) | 0 | 0 | 0 | 1 (0.2) |
| Non-cardiac chest pain | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
| Vestibular neuronitis | 0 | 0 | 1 (0.6) | 1 (0.3) | 1 (0.2) |
| Hyponatraemia | 1 (0.4) | 0 | 0 | 0 | 1 (0.2) |
| Back pain | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
| Intervertebral disc protrusion | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
| Fibroma | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
| Uterine leiomyoma | 1 (0.4) | 0 | 1 (0.6) | 1 (0.3) | 2 (0.3) |
| Migraine | 1 (0.4) | 0 | 0 | 0 | 1 (0.2) |
| Aged ≥ 60 years, n (%) | Placebo (n = 69) | Erenumab 70 mg (n = 38) | Erenumab 140 mg (n = 35) | Erenumab 70 + 140 mg (n = 73) | Total (N = 142) |
| Number of participants with at least one SAE | 0 | 0 | 0 | 0 | 0 |
Data pooled from phase 2 CM, STRIVE, ARISE, LIBERTY, and EMPOwER studies (safety analysis set). The summary contains TEAEs with onset day within the first 3 months (91 days) from the first administration of erenumab or placebo. A participant with multiple SAEs within a primary system organ class is counted only once in the total row. A participant with multiple occurrences of an SAE under one treatment is counted only once in this AE category for that treatment. System organ classes are presented in alphabetical order; preferred terms are sorted within system organ class in descending order of frequency in the 70/140 mg column, and then alphabetically. MedDRA Version which has been used for reporting is the same that was used in respective CSR analyses
Abbreviations: AE Adverse event, CM Chronic migraine, SAE Serious AE, TEAE Treatment-emergent AE